A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.320 enrolled

Overview

To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

320

Conditions

Hypertension

Interventions

EplerenoneDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 6-16 years old male and female * Systolic blood pressure greater than or equal to the 95th percentile for age, gender, and height, measured on at least 3 separate occasions Exclusion Criteria: * K/DOQI classification of stages of chronic kidney disease equal to or greater than 3 * Serum or whole blood potassium \> 5.5 mEq/L

Locations (41)

Outcomes

Primary Outcomes

Efficacy of eplerenone in children

Secondary Outcomes

Safety and tolerability of eplerenone in hypertensive children

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

Beverly Hills, California, United States

Pfizer Investigational Site

Inglewood, California, United States

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Jacksonville, Florida, United States

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

Augusta, Georgia, United States

Pfizer Investigational Site

Park Ridge, Illinois, United States

Pfizer Investigational Site

Louisville, Kentucky, United States

Pfizer Investigational Site

Shreveport, Louisiana, United States

...and 31 more locations